The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium
bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic
obstructive pulmonary disease (COPD)
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Adult male or non-pregnant, non-lactating female aged ≥40.
- Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
- Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a
post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
- Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and
Randomisation Visits
- Patient must be able to perform repeatable pulmonary function testing for FEV1
according to ATS/ERS 2005 criteria at Screening Visits
- Patients eligible and able to participate in the trial and who consent to do so in
writing after the purpose and nature of the investigation have been explained
Exclusion Criteria:
- History or current diagnosis of asthma
- Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or
3 months if hospitalisation was required) before the Screening Visit or during the
run-in period
- Clinically significant respiratory conditions
- Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism,
hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- Patients who, in the investigator's opinion, may need to start a pulmonary
rehabilitation programme during the study and/or patients who started/finished it
within 3 months prior to Screening Visit
- Use of long-term oxygen therapy (≥15 hours/day)
- Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks
prior to the Screening Visit
- Patient who does not maintain regular day/night, waking/sleeping cycles including
night shift workers
- Clinically significant cardiovascular conditions
- Patient with clinically relevant abnormalities in the results of the clinical
laboratory tests, ECG parameters or in the physical examination at the Screening
Visit
- Patient with a history of hypersensitivity reaction to inhaled anticholinergics,
sympathomimetic amines, or inhaled medication or any component thereof (including
report of paradoxical bronchospasm)
- Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute
urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
- Patient with known non-controlled history of infection with human immunodeficiency
virus (HIV) and/or active hepatitis
- History of malignancy of any organ system (including lung cancer), treated or
untreated, within the past 5 years other than basal or squamous cell skin cancer
- Patient with any other serious or uncontrolled physical or mental dysfunction
- Patient with a history (within 2 years prior to Screening Visit) of drug and/or
alcohol abuse that may prevent study compliance based on investigator judgment
- Patient unlikely to be cooperative or that can't comply with the study procedures
- Patient treated with any investigational drug within 30 days (or 6 half-lives,
whichever is longer) prior to Screening Visit
- Patient who intend to use any concomitant medication not permitted by this protocol
or who have not undergone the required stabilization periods for prohibited
medication
- Any other conditions that, in the investigator's opinion, might indicate the patient
to be unsuitable for the study
Almirall Investigational Site, Feldbach 8330, Austria
Almirall Investigational Site, Feldkirch 6800, Austria
Almirall Investigational Site, Grieskirchen A-4710, Austria
Almirall Investigational Site, Linz 4020, Austria
Almirall Investigational Site, Salzburg 5020, Austria
Almirall Investigational Site, Dimitrovgrad 6400, Bulgaria
Almirall Investigational Site, Gabrovo 5300, Bulgaria
Almirall Investigational Site, Kozlodui 3320, Bulgaria
Almirall Investigational Site, Petrich 2850, Bulgaria
Almirall Investigational Site, Plovdiv 4000, Bulgaria
Almirall Investigational Site, Razgrad 7200, Bulgaria
Almirall Investigational Site, Stara Zagora 6003, Bulgaria
Almirall Investigational Site, Vidin 3700, Bulgaria
Almirall Investigational Site, Karlovy Vary 360 09, Czech Republic
Almirall Investigational Site, Kralupy nad Vltavou 278 01, Czech Republic
Almirall Investigational Site, Liberec 460 63, Czech Republic
Almirall Investigational Site, Ostrava - Hrabuvka 700 30, Czech Republic
Almirall Investigational Site, Rokycany 337 01, Czech Republic
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Almirall Investigational Site, Nîmes 30900, France
Almirall Investigational Site, Perpignan 66025, France
Almirall Investigational Site, Vieux Conde 59690, France
Almirall Investigational Site, Berlin 10117, Germany
Almirall Investigational Site, Berlin 10629, Germany
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Almirall Investigational Site, Berlin 10969, Germany
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Almirall Investigational Site, Berlin 14059, Germany
Almirall Investigational Site, Bochum 44789, Germany
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Almirall Investigational Site, Cologne 51069, Germany
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Almirall Investigational Site, Dortmund 44263, Germany
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Almirall Investigational Site, Frankfurt 60389, Germany
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Almirall Investigational Site, Gauting 82131, Germany
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Almirall Investigational Site, Hamburg 20253, Germany
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Almirall Investigational Site, Warsaw 01-138, Poland
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Almirall Investigational Site, Vancouver, British Columbia BC V5Z 1M9, Canada
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Almirall Investigational Site, Moncton, New Brunswick NB E1C 5K4, Canada
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